# K983599: Safetex Chlamydia Trachomatis Specimen Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Andwin Scientific
- Decided: Dec 11, 1998 after 58 days
- Product code: HHT (Spatula, Cervical, Cytological)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SAFETEX Chlamydia trachomatis Direct Specimen Collection Kit is utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens from human subjects for chlamydial diagnostic testing.

Source page: https://510kreport.com/device/K983599
Methodology: https://510kreport.com/methodology